PARTICIPANT INFORMED CONSENT FORM

Title of Study: Recognition and Classification of Aggressive Movements using a Smartwatch

Principal Investigator (PI): Dr. Edward Lemaire, 613-737-8899 ext 75592

Funding Agency: Natural Science and Engineering Research Council of Canada (NSERC)

Participation in this study is voluntary. Please read this Participant Informed Consent Form carefully before you decide if you would like to participate. Ask the principal investigator and study team as many questions as you like. We encourage you to discuss your options with family, friends or your healthcare team.

Why am I being given this form?

You are being asked to participate in this research study to help us develop a method for identifying aggressive movementsfrom smartwatch sensor data.

Why is this study being done?

Aggressive behaviour can occur in clinical and elderly care settings with people suffering from dementia, mental disorders, or other conditions that affect behaviour. Since identifying the nature of the event can be difficult with people who have memory and communication issues, other methods to identify and record aggressive behaviour would be useful for care providers that need to determine the best methods to reduce or contain aggressive events.

Smartwatches are wearable devices that can be used to record arm movements and therefore could be used to determine if a particular motion is intended to be violent. This study will create and test a smartwatch app for human activity recording and aggressive movement detection. This approach could be used to identify if the person wearing the watch initiated the aggressive behaviour.

What is expected of me?

After having any questions answered by the project team and signing this consent form, a project assistant will write down your age, sex, weight, height, and handedness. You will be asked to wear aMicrosoft Band smartwatch on both wrists. You will also be asked to wear a smartphone on a belt at your lower back.

You will follow a circuit where you shake hands, puncha boxing bag, clap, wave goodbye, shove the boxing bag, push and pull a door, slap the boxing bag, type on a keyboardand shake the boxing bag.

Smartwatch sensor data will be recorded for the entire circuit. During the test, a member of the research team will record video of you with a second smartphone. This video will be used by the project team to relate your actions to the smartwatch sensor data.

Will my samples or research data be used in future research?

Sensor data from the smartwatch and smartphone may be used by other engineering researchers at TOHRC and other students for research on recognizing movements with wearable technology. This sensor data does not include personal information that would identify you. Video will not be used for future research since your actions will have already been recorded in the current study.

How long will I be involved in the study?

Your test session will be approximately 25 minutes, including the time to complete the consent form, wear the watch, and complete the circuit.

What are the potential risks I may experience?

You may experience discomfort in your hand or wrist after punching or slapping the boxing bag. The boxing bag has a foam cover and moves when hit, that reduces injury risk from hitting a hard surface.

Can I expect to benefit from participating in this research study?

You may not receive any direct benefit from participating in this study.

Do I have to participate?

Your participation in this study is voluntary. You may decide not to be in this study, or to be in the study now, and then change your mind later without affecting the medical care, education, or other services to which you are entitled or are presently receiving at this institution, or your relationship with employers at The Ottawa Hospital or at the University of Ottawa.

If I agree now, can I change my mind and withdraw later?

You may withdraw from the study at any time.Any information collected specifically for the research study will be destroyed in the event that you withdraw from the study.

What compensation will I receive if I am injured or become ill in this study?

In the event of a study-related injury or illness, you will be provided with appropriate medical treatment and care. You are not waiving any of your legal rights by agreeing to participate in this study. The Ottawa Hospital Rehabilitation Centre still has their legal and professional responsibilities.

How is my personal information being protected?

  • All personal health information (PHI) and your personal identifying information (PII), such as your name and age will be kept confidential.
  • Release of your PHI/PII information will only be allowed if it is legally required.
  • As a participant, you will be assigned a coded study number that will be used throughout the study on all your study records.
  • A Master List provides the link between your identifying information and the coded study number. This list will only be available to Dr. Lemaire and his staff and will not leave this site.
  • The Master List and coded study records will be stored securely in a password protected computer and locked file cabinet.
  • For audit purposes only, your research records may be reviewed under the supervision of Dr. Lemaire staff by representatives from:
  • the Ottawa Health Science Network Research Ethics Board (OHSN-REB) and
  • the Ottawa Hospital Research Institute
  • The University of Ottawa
  • You will not be identified in any publications or presentations resulting from this study.
  • Research records will be kept for 10 years, as required by the OHSN-REB.
  • At the end of the storage time, all paper records will be shredded and all electronic records will be securely deleted.

Do the investigators have any conflicts of interest?

There are no conflicts of interest to declare related to this study. The Principal Investigator is receiving financial payment from the funding sourceto cover the cost of conducting this study.

What are my responsibilities as a study participant?

It is important to remember the following things during this study:

•Ask the project assistant if you have any questions or concerns.

Who do I contact if I have any further questions?

If you have any questions about this study, or if you feel that you have experienced a study-related injury or illness, please contact Dr. Edward Lemaire at 613-737-7350 x75592 or .

The Ottawa Health Science Network Research Ethics Board (OHSN-REB) has reviewed this protocol. The Board considers the ethical aspects of all research studies involving human participants at the Ottawa Hospital Rehabilitation Centre. If you have any questions about your rights as a study participant, you may contact the Chairperson at 613-798-5555, extension 16719.

Recognition and Classification of Aggressive Movements using a Smartwatch

Consent to Participate in Research

  • I understand that I am being asked to participate in a research study about smartwatch detection of aggressive movements.
  • This study was explained to me by a project assistant.
  • I have read, or someone has read to me, each page of this Participant Informed Consent Form.
  • All of my questions have been answered to my satisfaction.
  • If I decide later that I would like to withdraw my participation and/or consent from the study, I can do so at any time.
  • I voluntarily agree to participate in this study.
  • I will be given a copy of this signed Participant Informed Consent Form.

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Participant’s Printed Name Participant’s Signature Date

Investigator or Delegate Statement

I have carefully explained the study to the study participant. To the best of my knowledge, the participant understands the nature, demands, risks and benefits involved in taking part in this study.

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Investigator/Delegate’s Printed Name Investigator/Delegate’s Signature Date

Version Date: July 27, 2017Page 1 of 4